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临床试验/EUCTR2007-004790-25-DE
EUCTR2007-004790-25-DE进行中(未招募)不适用

Evaluation of the benefit of fluorescence diagnostics using Metvix® and the Dyaderm system for the preoperational estimation of the lateral tumour spread in basal cell carcinomas. - FD-BZK

niversity of Leipzig0 个研究点开始时间: 2009年7月30日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Basal cell carcinoma, clinically or histologically ascertained
  • Size of tumor 0,5 to 1,5 cm
  • Age = 18 years
  • Written informed consent of the patient
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Other tumors
  • Basal cell carcinoma, pigmented subtype; sclerodermiform subtype
  • Patients suffering from porphyrie
  • Hypersensitivity to methyl(5-amino-4oxopentanoat)hydrochloride, any other component of the cream or peanut oil
  • Insufficient compliance
  • Women during pregnancy and lactation
  • Fertile women (< than two years after their last menstruation) without a highly effective method of birth control (defined as those which result in a low failure rate - i.e. less than 1% per year when used consistently and correctly - such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) during the clinical trial. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
  • Concurrent participation in other clinical trials

研究者

发起方
niversity of Leipzig

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